A Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia

October 1, 2008 updated by: Pfizer

A Phase 1B Inpatient, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Of The Safety And Efficacy Of Two Fixed Doses Of PF-3463275 In Adjunctive Treatment Of Cognitive Deficits In Schizophrenia

The objective of this study is to evaluate the safety, tolerability, and efficacy of two dose regimens of PF-3463275 compared with placebo added to ongoing atypical antipsychotic therapy for cognitive deficits in subjects with chronic symptoms of schizophrenia.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Glendale, California, United States, 91206
        • Pfizer Investigational Site
    • New Jersey
      • Willingboro, New Jersey, United States, 08046
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of schizophrenia
  • In stable treatment with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone for at least 2 months
  • Stable symptoms of schizophrenia for at least 3 months.

Exclusion Criteria:

  • Subjects with a psychiatric disorder other than schizophrenia
  • Substance dependence or abuse
  • Women who have child bearing potential.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
PF-3463275 10mg
PF-3463275 25mg
Experimental: 2
PF-3463275 10mg
PF-3463275 25mg
Placebo Comparator: 3
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the CNS Vital Signs Cognition Battery composite score
Time Frame: 6 days
6 days
Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's.
Time Frame: 38 days
38 days
Pharmacokinetics of PF-3463275
Time Frame: 6 days
6 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Positive and Negative Syndrome Scale (PANSS)
Time Frame: 6 days
6 days
Change from baseline in the CNS Vital Signs Cognition Battery domain scores
Time Frame: 6 days
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

December 3, 2007

First Submitted That Met QC Criteria

December 3, 2007

First Posted (Estimate)

December 4, 2007

Study Record Updates

Last Update Posted (Estimate)

October 2, 2008

Last Update Submitted That Met QC Criteria

October 1, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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